# K080463: Alma Lasers Thermoxel CO2 Laser System and Delivery Device Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Alma Lasers, Ltd.
- Decided: Jul 23, 2008 after 154 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K936109 (1994). 28 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063001: Slim Evolution Family of CO2 Lasers and Delivery Device Accessories, Lasering S.R.L. (2007) Summary page 1.
- K040234: Laserpro CO2 Carbon Dioxide Laser System, Photo Medex, Inc. (2004) Summary page 1.
- K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers, Lumenis, Ltd. (2003) Summary page 1.
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories, Lumenis, Inc. (2002) Summary page 1.

## Most influential descendants
- K103501: Alma Lasers Pixel CO2 Laser System, Delivery Device and Accessories (2011), 13 descendants of its own
- K203441: The Alma Hybrid Laser System (2021), 5 descendants of its own
- K141658: Light Scalpel (2014), 2 descendants of its own
- K101321: Ematrix CO2 (2010), 2 descendants of its own
- K233024: Alma Harmony (2024), 1 descendant of its own

## Indications for use
The Alma Lasers ThermoXELTM CO 2 Laser System and Delivery Device Accessories are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee). The Alma Lasers ThermoXELTM CO 2 Laser System is cleared for use for the particular indications as follows: Dermatololiy & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: * laser skin resurfacing * laser derm-abrasion * laser bum debridement. Laser skin resurfacing (ablation and/or vaporization) for the treatment of: * wrinkles, rhytids, and furrows (including fines lines and texture irregularities) Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO 2 laser increases the amount of sub-epidermal collagen. Dermatolo2y & Plastic Suriiery, continued Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: * keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheic wart,. and verruca seborrheica; * vermillionectomy of the lip; * cutaneous horns; * solar/actinic elastosis; * chelitis, including actinic chelitis; * lentigines, including lentigo maligna or Hutchinson's malignant freckle; * uneven pigmentation/ dyschromia; * acne scars; * surgical scars; * keloids including acne keloidalis nuchae; * hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum); * tattoos; * telangiectasia; * removal of small skin tumors, including periungual (Koenen) and subungual fibromas; * superficial pigmented lesions; * adenosebaceous hypertrophy or sebaceous hyperplasia; * rhinophyma reduction; * cutaneous papilloma (skin tags); * milia; * debridement of eczematous or infected skin; * basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions; Dermatolojy & Plastic Surgery. continued * nevi, including spider, epidermal and protruding; * neurofibromas; * laser de-epithelialization; * tricoepitheliomas; * xanthelasma palpebrarum; * syringoma Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization/coagulation of: * benign/malignant vascular/avascular skin lesions; * Moh's Surgery; * Lipectomy; * Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungaual warts. Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty. Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation. Podiatry Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of: * verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts; * fungal nail treatment; * porokeratoma ablation; * ingrown nail treatment; * neuromas/fibromas, including Morton's neuroma; * debridement of ulcers; * other soft tissue lesions. Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy. Otolaryngology (ENT) Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of: * choanal atresia, * leukoplakia, including oral, larynx, uvula, palatal, upper lateral pharyngeal tissue; * nasal obstruction; * adult and juvenile papillomatosis polyps; * polypectomy of nose and nasal passages; * lymphangioma removal; * removal of vocal cord/fold nodules, polyps and cysts; * removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords; Otolaryniology (ENT), continued * laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue; * Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-assisted esophagodivertuculostomy (ELAED)]; * stenosis, including subglottic stenosis; * tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy; * pulmonary bronchial and tracheal lesion removal; * benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial/endobronchial); * benign and malignant lesions and fibromas (nose and nasal passages); * benign and malignant tumors and fibromas; (oral); * stapedotomy/stapedectomy; * acoustic neuroma in the ear; * superficial lesions of the ear, including chondrodermatitis nondularis chronica helices/Winkler's disease; * telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue); * cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea; * myringotomy/tympanostomy (tympanic membrane fenestration); * uvulopalatoplasty (LAUP, laser UPPP); * turbinectomy and turbinate reduction/ablation); * septal spur ablation/reduction and septoplasty; * partial glossectomy; * tumor resection on oral, subfacial and neck tissues; * rhinophyma; * verrmcae vulgares (warts); * gingivoplasty/gingivoctomy. Gynecolog¥ (GYN) Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of: * conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN); * condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions; * leukoplakia (vulvar dystrophies); * incision and drainage (I&D) of Bartholin's and nubuthian cysts; * herpes vaporization; * urethral caruncle vaporization; * cervical dysplasia; * benign and malignant tumors; * hemangiomas. GYN Laparoscopy Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of: * endometrial lesions, including ablation of endometriosis; * excision/lysis of adhesions; * salpingostomy; * oophorectomy/ovariectomy; * fimbroplasty; * metroplasty; * microsurgery (tubal); * uterine myomas and fibroids; GYN Laparoscopy, continued * ovarian fibromas and follicle cysts; * uterosacral ligament ablation; * hysterectomy. Neurosurgery Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of: Cranial * posterior fossa tumors; * peripheral neurectomy; * benign and malignant tumors and cysts (e.g. gliomas, menigiomas (including basal tumors), acoustic neuromas, lipomas and large tumors); * arteriovenous malformation; * pituitary gland tumors (transphenoidal approach). Spinal Cord * incision/excision and vaporization of benign and malignant tumors and cysts; * intra- and extradural lesions; * laminectomy/ laminotomy/ microdiscectomy. Orthopedics Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include: Arthroscopy * menisectomy; * chodromalacia; * chondroplasty; * ligament release (lateral and other); * excision of plica; * partial synovectomy. General * deridement of traumatic wounds; * debridement of decubitus and diabetic ulcers; * microsurgery; * artificial joint revision; * PMMA removal. General/Thoracic Surgery Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include: * debridement of decubitus ulcers, stasis, diabetic and other ulcers; * mastectomy; * debridement of bums; * rectal and anal hemorrhoidectomy; * breast biopsy; General/Thoracic Surgery, continued * reduction mammoplasty; * cytoreduction for metastatic disease; * laparotomy and laparoscopic applications; * mediastinal and thoracic lesions and abnormalities; * skin tag vaporization; * atheroma; * cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips; * pilonidal cyst removal and repair; * abscesses; * other soft tissue applications. Dental/Oral Surgery Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: * gingivectomy- removal of hyperplasias; * gingivoplasty; * incisional and excisional biopsy; * treatment of ulcerous lesions, including aphthous ulcers; * incision of infection when used with antibiotic therapy; * frenectomy (frenum release); * excision and ablation of benign and malignant lesions; * homeostasis; * operculectomy; * crown lengthening; Dental/Oral Surgery, continued * removal of soft tissue, cysts and tumors; * oral cavity tumors and hemangiomas; * abscesses; * extraction site hemostasis; * salivary gland pathologies;, * preprosthetic gum preparation; * leukoplakia; * partial glossectomy; * periodontal gum resection. Genitourinary Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include: * benign and malignant lesions of external genitalia; * condyloma; * phimosis * 'erythroplasia. The Alma Lasers ThermoXELTM CO 2 Laser System Pixel Handpieces are indicated for use in soft tissue for: Dermatoloey & Plastic Surgery * Skin resurfacing

Source page: https://510kreport.com/device/K080463
Methodology: https://510kreport.com/methodology